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Clinical Trials in China / NCT03463252
Recruiting Phase 2/3

Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC

NCT03463252 · tracked via the Priya Life Science China tracker
Sponsor
West China Second University Hospital
Phase
Phase 2/3
Started
2018-04-01
Last updated
2021-09-13

Condition(s) studied

Endometrial CancerAtypical Endometrial Hyperplasia

Investigational drug(s) / intervention(s)

ProgesteroneMirena®GnRH agonist

Progesterone: MPA oral 250mg-500mg qd for 3 months per cycle

Mirena®: levonorgestrel intrauterine sustained release system (LNG-IUS) placed in uterus for 3 months per cycle

GnRH agonist: GnRH-a intramuscular injection 3.75mg once a month for 3 months per cycle

Study summary

Primary end points:

This clinical trial is aimed to analyze the effectiveness of Levonorgestrel-Releasing Intrauterine System (LNG-IUS, Mirena®) in the fertility-sparing treatment of atypical endometrial hyperplasia and early endometrial carcinoma, including pathology response and pregnancy outcome.

Second end points:

To analyze the appearances of side-effects.

Eligibility

Sex
FEMALE
Min age
Max age
40 Years
Healthy volunteers
No
For Patients With Endometrial Cancer: Inclusion Criteria: * ≤40 years of age: * Having a strong desire for fertility preservation; * Histological diagnosis is confirmed as well-differentiated (grade 1) endometrioid adenocarcinoma by the designated gynecological pathologists, and the progesterone receptors (PgRs) is positive in immunohistochemistry; * Disease limited to the endometrium (stage 1A) on MRI; * Serum CA125/199 level is within normal limit (Laparoscopic exploration to rule out ovarian tumor or another metastasis if necessary); * Patients should have undergone counseling to learn fertility-preserving treatment is not standard of care for the treatment of EC, volunteered to participate in this study, signed the informed consent form, and agreed to participated in clinical follow-up. Exclusion Criteria: * Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs; * Patients have lynch syndrome (LS); * Patients have contraindications for pregnancy; * Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute liver or kidney diseases, acute or subacute genital tract infections and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible); * Patients refuse to participate in clinical follow-up or sign the informed consent form. For Patients With Endometrial atypical hyperplasia: Inclusion Criteria: * ≤ 40 years of age * Having a strong desire for fertility preservation * Histological diagnosis is confirmed as atypical endometrial hyperplasia (EAH) by the designated gynecological pathologists * Having volunteered to participate in this study, signed the informed consent form, and agreed to participate in clinical follow-up Exclusion Criteria: * Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs * Patients have contraindications for pregnancy * Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute or subacute genital tract infections, and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible) * Patients refuse to participate in clinical follow-up or sign the informed consent form.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
West China Second University Hospital Chengdu Sichuan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03463252 on ClinicalTrials.gov ↗ ← All trials in China